Approval Probability
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Adjusted LOA
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PF-06650833 · 3 trials · 2 indications
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.
HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
| Arm | Type | Description |
|---|---|---|
| PF-06650833 + tofacitinib | EXPERIMENTAL | - |
| PF-06650833 + PF-06651600 | EXPERIMENTAL | - |
| PF-06650833 | EXPERIMENTAL | - |
| PF-06651600 | EXPERIMENTAL | - |
| Tofacitinib | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | PF-06650833 |
| Cohort 2 | EXPERIMENTAL | PF-6700841 |
| Cohort 3 | EXPERIMENTAL | PF-06826647 |
| Cohort placebo | PLACEBO_COMPARATOR | placebo |
| Arm 1: 20 mg QD | EXPERIMENTAL | PF-06650833 , 20 mg QD |
| Arm 2: 60 mg QD | EXPERIMENTAL | PF-06650833, 60 mg QD |
| Arm 3: 200 mg QD | EXPERIMENTAL | Pf-06650833, 200 mg QD |
| Arm 4: 400 mg QD | EXPERIMENTAL | PF-06650833, 400 mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo, 0 mg BID |
| Arm 5: Tofacitinib | ACTIVE_COMPARATOR | Tofacitinib 5 mg BID |
| Name | Type | Description |
|---|---|---|
| PF-06650833 | DRUG | 400 mg |
| PF-06651600 | DRUG | 100 mg |
| Tofacitinib | DRUG | 11 mg |
| PF-06700841 | DRUG | 45 mg QD |
| PF-06826647 | DRUG | 400 mg QD |
| Placebo | DRUG | placebo |
Inclusion Criteria: * Male or female participants between the ages of 18 and 70 years. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Diagnosis of RA and meeting the 2010 American...
PF-06650833 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It is being studied in Phase 2 clinical trials for hidradenitis suppurativa (acne inversa) and rheumatoid arthritis. It has not been approved by the FDA and remains in clinical development.
PF-06650833 is being evaluated for the treatment of hidradenitis suppurativa (also called acne inversa) and rheumatoid arthritis. Both are inflammatory conditions. The drug is investigational and has not been approved for any indication.
PF-06650833 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating this drug.
PF-06650833 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval.
PF-06650833 has been studied in three completed Phase 2 trials: NCT04413617 in rheumatoid arthritis, NCT04092452 in hidradenitis suppurativa, and NCT02996500 in rheumatoid arthritis. All trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 729 participants.